Let’s consider a controversial chemical: phenylalanine. Also known as aspartame, also known as NutraSweet, sometimes known as Sweet and Low, phenylalanine is an artificial sweetener that has been given the designation “generally recognized as safe,” or GRAS (yes…gras…the French word for ‘fat’) by the Food and Drug Administration.

But who determines what is generally recognized as safe? What scientific means are used to determine whether or not something is safe. Do they conduct surveys of scientific literature to synthesize the conclusions of other scientists, or do they conduct studies of their own?

Yet another problem: If something is generally recognized as safe, that inherently doesn’t mean that it’s safe, right? Otherwise it would just be called “safe.”

We’re going to look at how a chemical like aspartame becomes “generally recognized as safe,” and we’re going to consider flaws in the process so that we can get a more complete picture of what this designation means and what impact it should have on your consumption decisions.


On New Year’s Day 1958, a law went into effect called the Food Additives Amendment of 1958. The act presented a list of 700 food substances that food manufacturers would not have to test, but were “generally recognized as safe.” Since then, the FDA has added more substances to this list to take the burden of testing off of food companies.


Though the list started with substances the FDA listed itself, it has grown to include submissions from companies that have gone so far as to do their own research and submit it to the agency. Thus there are two paths a substance can take to become generally recognized as safe for human consumption: Self-affirmed and by FDA Response to GRAS notification

Self-affirmed: Self-affirmed means that the FDA has gone so far as to affirm the safety of the substance independent of the businesses who use it. The FDA does this through its own internal research of the substance in question

FDA Response to GRAS Notification: This is when a company does its own due diligence, either in-house or through a third party of non-governmental experts.


First, companies schedule a pre-submission meeting with the FDA to talk about potential problems or challenges facing the review process. Then you are ready to submit a “GRAS Notice.” Of course, the GRAS notice must consist of research conducted by experts in relevant fields.

According to the FDA’s website, “The notice should include information about the identity and properties of the substance and a discussion of the notifier’s reasons for concluding that the substance is GRAS for its intended use. The information about the notified substance generally is chemical, toxicological, and, if applicable, microbiological in nature.”

As a matter of policy, the notifier must submit any information that may cause the substance to be considered inconsistent with a GRAS designation [of course, let’s keep in mind that trans fats were a GRAS substance until 2015. Literally a GRAS substance! (Gras is the French word for fat, c’mon pay attention!)].

After the notification is submitted, there are steps the FDA must take on their side. Within 30 days of when the notification is sent, the FDA will write back and let the notifier know they’ve gotten the notification. The FDA then looks over the document to determine whether it’s even worth reading (whether it meets all of the necessary requirements information-wise). If they have all the necessary information, they will then review that information and convene a panel of experts to determine whether the substance is safe.

Depending on the panel’s findings, the agency will issue one of three types of letters. The first says that the FDA does not question the notifier’s claim that the substance is GRAS. The second type of letter determines that the substance does not have enough evidence to say that it is GRAS. The third letter indicates that the agency has ceased to evaluate the notice, at the notifier’s request.

Track Record

So do substances fall through the cracks and are still listed GRAS? Yes! The process is littered with loopholes so that substances like Red #3, a proven toxin, are still allowed in foods everywhere. Despite a lot of the pomp and circumstance, these designations are not perfect. Trans fats were discovered to have negative health effects in the early 1990s, but their GRAS designation wasn’t removed until 2015.

The reason for this is because lobbying firms have connections within the FDA. People who previously worked for big food companies, also end up finding work in the FDA. There’s even direct corruption in the form of pay-to-play, but in a limited way. Essentially, the FDA is not immune to those corrupting forms of influences that plague other regulatory bodies.

Also, companies that fund the research themselves often have biases in the research and will have their scientists emphasize positive findings about substances over negative ones. This is why the federal government must continue to fund research into the edibility of new substances that those in the food industry might wish to use as ingredients.


Chad Weisman—CEO, Golden Strands Communication; ‘creative type’; surfer on the amber waves of grain; avid concert attendee.